SPL Mapping FHIR R5 Implementation Guide
0.2.8 - Build CI United States of America flag

SPL Mapping FHIR R5 Implementation Guide, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.2.8 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-spl/ and changes regularly. See the Directory of published versions

Logical Model: Product Submission Document Logical Model

Official URL: http://hl7.org/fhir/us/spl/StructureDefinition/ProductSubmissionDocumentLogicalModel Version: 0.2.8
Standards status: Trial-use Maturity Level: 1 Computable Name: ProductSubmissionDocumentLogicalModel

A document that contains information about a product being submitted for approval to the FDA.

Product Submission Document UML Diagram

The following UML diagram shows the data elements of a Product Submission Document. More details about the data elements can be found in the definition tables below.

A Product Submission is done as a Document with metadata about the document such as:

  • identifier
  • title
  • type
  • author

The body of the document is broken into sections (which can have sub-sections) where each section corresponds to a logical grouping of information about the product. Each section has the following information:

  • identifier
  • written date/time
  • title
  • type

It also has human readable text (or a set of human readable highlights). One of the sections may also have detailed information about the submitted product.

ProductSubmissionDocumentstring identifierdate splVersionstring submissionIdentifierpositiveInt versionNumberCodeableConcept typestring title 0..1RelatedDocumentstring identifierstring submissionIdentifierpositiveInt versionNumberLabelerstring dunsNumberstring nameEstablishmentstring dunsNumberstring nameRegistrantstring dunsNumberstring nameBusinessOperationCodeableConcept codeCodeableConcept productNDC 0..1Sectionstring identifierdateTime effectiveTimeCodeableConcept typestring title 0..1xhtml text 0..1xhtml highlights 0..1SubmittedProduct product 0..*Imagestring titleurl reference1..10..*1..*1..*0..*0..*

Usages:

  • This Logical Model is not used by any profiles in this Implementation Guide

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ProductSubmissionDocumentLogicalModel 0..* Element
Elements defined in Ancestors:@id, extension
Product Submission Document Logical Model
... @id 0..1 string Unique id for inter-element referencing
... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
... identifier 1..1 string Document Identifier
... submissionIdentifier 1..1 string Submission Identifier
... versionNumber 1..1 positiveInt Document Version Number
... type 1..1 CodeableConcept Document Type
... title 0..1 string Document Title
... labeler 1..1 BackboneElement Product Labeler
.... @id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... dunsNumber 1..1 string Product Labeler DUNS Number
.... name 1..1 string Product Labeler Name
.... registrant 0..1 BackboneElement Product Labeler Registrant
..... @id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... dunsNumber 1..1 string Registrant DUNS Number
..... name 1..1 string Registrant Name
..... establishment 1..* BackboneElement Product Establishment
...... @id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... dunsNumber 1..1 string Establishment DUNS Number
...... name 1..1 string Establishment Name
...... businessOperation 1..* BackboneElement Establishment Business Operations
....... @id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... code 1..1 CodeableConcept Business Operation Type
....... productNDC 0..1 CodeableConcept Business Operation Product NDC
... relatedDocument 0..* BackboneElement Reference to Related Document
.... @id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... identifier 1..1 string Related Document Identifier
.... submissionIdentifier 1..1 string Related Document Submission Identifier
.... versionNumber 1..1 positiveInt Related Document Version Number
... section 1..* BackboneElement Document Sections
.... @id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... identifier 1..1 string Section Identifier
.... effectiveTime 1..1 date Section Effective Time
.... type 1..1 CodeableConcept Section Type
.... title 0..1 string Section Title
.... text 0..1 xhtml Section Text
.... highlights 0..1 xhtml Section Text Highlights
.... image 0..* BackboneElement Section Images
..... @id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... name 1..1 string Image Title
..... reference 1..1 url Image Reference
.... product 0..* SubmittedMedicationLogicalModel Section Product Information
.... subsection 0..* See section subsection

doco Documentation for this format

Constraints

IdGradePath(s)DetailsRequirements
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from Element

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ProductSubmissionDocumentLogicalModel 0..* Element
Elements defined in Ancestors:@id, extension
Product Submission Document Logical Model
... identifier 1..1 string Document Identifier
... splVersion 1..1 date Document SPL Version
... submissionIdentifier 1..1 string Submission Identifier
... type 1..1 CodeableConcept Document Type
... title 0..1 string Document Title
... labeler 1..1 BackboneElement Product Labeler
.... dunsNumber 1..1 string Product Labeler DUNS Number
.... name 1..1 string Product Labeler Name
.... registrant 0..1 BackboneElement Product Labeler Registrant
..... dunsNumber 1..1 string Registrant DUNS Number
..... name 1..1 string Registrant Name
..... establishment 1..* BackboneElement Product Establishment
...... dunsNumber 1..1 string Establishment DUNS Number
...... name 1..1 string Establishment Name
...... businessOperation 1..* BackboneElement Establishment Business Operations
....... code 1..1 CodeableConcept Business Operation Type
....... productNDC 0..1 CodeableConcept Business Operation Product NDC
... relatedDocument 0..* BackboneElement Reference to Related Document
.... identifier 1..1 string Related Document Identifier
.... submissionIdentifier 1..1 string Related Document Submission Identifier
.... versionNumber 1..1 positiveInt Related Document Version Number
... section 1..* BackboneElement Document Sections
.... identifier 1..1 string Section Identifier
.... effectiveTime 1..1 date Section Effective Time
.... type 1..1 CodeableConcept Section Type
.... title 0..1 string Section Title
.... text 0..1 xhtml Section Text
.... highlights 0..1 xhtml Section Text Highlights
.... image 0..* BackboneElement Section Images
..... name 1..1 string Image Title
..... reference 1..1 url Image Reference
.... product 0..* SubmittedMedicationLogicalModel Section Product Information
.... subsection 0..* See section subsection

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ProductSubmissionDocumentLogicalModel 0..* Element
Elements defined in Ancestors:@id, extension
Product Submission Document Logical Model
... @id 0..1 string Unique id for inter-element referencing
... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
... identifier 1..1 string Document Identifier
... submissionIdentifier 1..1 string Submission Identifier
... versionNumber 1..1 positiveInt Document Version Number
... type 1..1 CodeableConcept Document Type
... title 0..1 string Document Title
... labeler 1..1 BackboneElement Product Labeler
.... @id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... dunsNumber 1..1 string Product Labeler DUNS Number
.... name 1..1 string Product Labeler Name
.... registrant 0..1 BackboneElement Product Labeler Registrant
..... @id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... dunsNumber 1..1 string Registrant DUNS Number
..... name 1..1 string Registrant Name
..... establishment 1..* BackboneElement Product Establishment
...... @id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... dunsNumber 1..1 string Establishment DUNS Number
...... name 1..1 string Establishment Name
...... businessOperation 1..* BackboneElement Establishment Business Operations
....... @id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... code 1..1 CodeableConcept Business Operation Type
....... productNDC 0..1 CodeableConcept Business Operation Product NDC
... relatedDocument 0..* BackboneElement Reference to Related Document
.... @id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... identifier 1..1 string Related Document Identifier
.... submissionIdentifier 1..1 string Related Document Submission Identifier
.... versionNumber 1..1 positiveInt Related Document Version Number
... section 1..* BackboneElement Document Sections
.... @id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... identifier 1..1 string Section Identifier
.... effectiveTime 1..1 date Section Effective Time
.... type 1..1 CodeableConcept Section Type
.... title 0..1 string Section Title
.... text 0..1 xhtml Section Text
.... highlights 0..1 xhtml Section Text Highlights
.... image 0..* BackboneElement Section Images
..... @id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... name 1..1 string Image Title
..... reference 1..1 url Image Reference
.... product 0..* SubmittedMedicationLogicalModel Section Product Information
.... subsection 0..* See section subsection

doco Documentation for this format

Constraints

IdGradePath(s)DetailsRequirements
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from Element

Summary

Mandatory: 0 element(24 nested mandatory elements)

Maturity: 1

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ProductSubmissionDocumentLogicalModel 0..* Element
Elements defined in Ancestors:@id, extension
Product Submission Document Logical Model
... @id 0..1 string Unique id for inter-element referencing
... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
... identifier 1..1 string Document Identifier
... submissionIdentifier 1..1 string Submission Identifier
... versionNumber 1..1 positiveInt Document Version Number
... type 1..1 CodeableConcept Document Type
... title 0..1 string Document Title
... labeler 1..1 BackboneElement Product Labeler
.... @id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... dunsNumber 1..1 string Product Labeler DUNS Number
.... name 1..1 string Product Labeler Name
.... registrant 0..1 BackboneElement Product Labeler Registrant
..... @id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... dunsNumber 1..1 string Registrant DUNS Number
..... name 1..1 string Registrant Name
..... establishment 1..* BackboneElement Product Establishment
...... @id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... dunsNumber 1..1 string Establishment DUNS Number
...... name 1..1 string Establishment Name
...... businessOperation 1..* BackboneElement Establishment Business Operations
....... @id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... code 1..1 CodeableConcept Business Operation Type
....... productNDC 0..1 CodeableConcept Business Operation Product NDC
... relatedDocument 0..* BackboneElement Reference to Related Document
.... @id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... identifier 1..1 string Related Document Identifier
.... submissionIdentifier 1..1 string Related Document Submission Identifier
.... versionNumber 1..1 positiveInt Related Document Version Number
... section 1..* BackboneElement Document Sections
.... @id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... identifier 1..1 string Section Identifier
.... effectiveTime 1..1 date Section Effective Time
.... type 1..1 CodeableConcept Section Type
.... title 0..1 string Section Title
.... text 0..1 xhtml Section Text
.... highlights 0..1 xhtml Section Text Highlights
.... image 0..* BackboneElement Section Images
..... @id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... name 1..1 string Image Title
..... reference 1..1 url Image Reference
.... product 0..* SubmittedMedicationLogicalModel Section Product Information
.... subsection 0..* See section subsection

doco Documentation for this format

Constraints

IdGradePath(s)DetailsRequirements
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

Differential View

This structure is derived from Element

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ProductSubmissionDocumentLogicalModel 0..* Element
Elements defined in Ancestors:@id, extension
Product Submission Document Logical Model
... identifier 1..1 string Document Identifier
... splVersion 1..1 date Document SPL Version
... submissionIdentifier 1..1 string Submission Identifier
... type 1..1 CodeableConcept Document Type
... title 0..1 string Document Title
... labeler 1..1 BackboneElement Product Labeler
.... dunsNumber 1..1 string Product Labeler DUNS Number
.... name 1..1 string Product Labeler Name
.... registrant 0..1 BackboneElement Product Labeler Registrant
..... dunsNumber 1..1 string Registrant DUNS Number
..... name 1..1 string Registrant Name
..... establishment 1..* BackboneElement Product Establishment
...... dunsNumber 1..1 string Establishment DUNS Number
...... name 1..1 string Establishment Name
...... businessOperation 1..* BackboneElement Establishment Business Operations
....... code 1..1 CodeableConcept Business Operation Type
....... productNDC 0..1 CodeableConcept Business Operation Product NDC
... relatedDocument 0..* BackboneElement Reference to Related Document
.... identifier 1..1 string Related Document Identifier
.... submissionIdentifier 1..1 string Related Document Submission Identifier
.... versionNumber 1..1 positiveInt Related Document Version Number
... section 1..* BackboneElement Document Sections
.... identifier 1..1 string Section Identifier
.... effectiveTime 1..1 date Section Effective Time
.... type 1..1 CodeableConcept Section Type
.... title 0..1 string Section Title
.... text 0..1 xhtml Section Text
.... highlights 0..1 xhtml Section Text Highlights
.... image 0..* BackboneElement Section Images
..... name 1..1 string Image Title
..... reference 1..1 url Image Reference
.... product 0..* SubmittedMedicationLogicalModel Section Product Information
.... subsection 0..* See section subsection

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ProductSubmissionDocumentLogicalModel 0..* Element
Elements defined in Ancestors:@id, extension
Product Submission Document Logical Model
... @id 0..1 string Unique id for inter-element referencing
... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
... identifier 1..1 string Document Identifier
... submissionIdentifier 1..1 string Submission Identifier
... versionNumber 1..1 positiveInt Document Version Number
... type 1..1 CodeableConcept Document Type
... title 0..1 string Document Title
... labeler 1..1 BackboneElement Product Labeler
.... @id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... dunsNumber 1..1 string Product Labeler DUNS Number
.... name 1..1 string Product Labeler Name
.... registrant 0..1 BackboneElement Product Labeler Registrant
..... @id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... dunsNumber 1..1 string Registrant DUNS Number
..... name 1..1 string Registrant Name
..... establishment 1..* BackboneElement Product Establishment
...... @id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... dunsNumber 1..1 string Establishment DUNS Number
...... name 1..1 string Establishment Name
...... businessOperation 1..* BackboneElement Establishment Business Operations
....... @id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... code 1..1 CodeableConcept Business Operation Type
....... productNDC 0..1 CodeableConcept Business Operation Product NDC
... relatedDocument 0..* BackboneElement Reference to Related Document
.... @id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... identifier 1..1 string Related Document Identifier
.... submissionIdentifier 1..1 string Related Document Submission Identifier
.... versionNumber 1..1 positiveInt Related Document Version Number
... section 1..* BackboneElement Document Sections
.... @id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... identifier 1..1 string Section Identifier
.... effectiveTime 1..1 date Section Effective Time
.... type 1..1 CodeableConcept Section Type
.... title 0..1 string Section Title
.... text 0..1 xhtml Section Text
.... highlights 0..1 xhtml Section Text Highlights
.... image 0..* BackboneElement Section Images
..... @id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... name 1..1 string Image Title
..... reference 1..1 url Image Reference
.... product 0..* SubmittedMedicationLogicalModel Section Product Information
.... subsection 0..* See section subsection

doco Documentation for this format

Constraints

IdGradePath(s)DetailsRequirements
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from Element

Summary

Mandatory: 0 element(24 nested mandatory elements)

Maturity: 1

 

Other representations of profile: CSV, Excel